It was reported that prior to use, the seal pouch of the dragonfly optis imaging catheter device was found damaged and the sterility was compromised.Therefore, the device was not used in the patient and the procedure was completed with another dragonfly optis imaging catheter.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Visual analysis was performed on the returned device.The reported unsealed packaging was unable to be confirmed as the packaging materials were not received.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar complaints reported from this lot.The investigation was unable to determine a cause for the reported unsealed device packaging.It may be possible that the packaging was previously opened at the account with the intention to be used in a previous procedure but was never used and the product was placed back into the accounts inventory; or the packaging pouch was damaged/compromised while in storage; however, these conditions could not be confirmed.The product pouch/packaging was not returned with the complaint product.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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